NCT02658968

Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05)

A Phase 1 Dose Finding Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin®) in Patients With Relapsed/Refractory, Diffuse Large B-cell Lymphoma, Not Eligible for Autologous Stem Cell Transplant

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Nordic Nanovector · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase 1, dose finding, open-label study in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This is a dose escalating study to define the maximum tolerated dose (MTD) of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) in DLBCL patients who are not eligible for autologous stem cell transplant. The study will also assess safety and tolerability, pharmacokinetics, biodistribution and efficacy.

Conditions

• Relapsed, Diffuse Large B-cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Betalutin	Dose finding study, starting on 10 MBq/kg b.w. Betalutin® (lutetium (177Lu)-lilotomab satetraxetan), single injection with lilotomab pre-dosing.

Timeline

• Start date: 2017-03-02
• Primary completion: 2021-06-04
• Completion: 2021-07-10
• First posted: 2016-01-20
• Last updated: 2024-01-16
• Results posted: 2024-01-16

Locations

10 sites across 5 countries: United States, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study